MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: unknown.Detailed description of event: hospital: [name]."the valve part broke down and dropped off from the center of the cap, when the surgeon inserted the 12 mm kii trocker into the cap during the treatment.As we checked the actual product, it was broken." [name] has two questions as below: have you had the same product imperfection on the same lot#1361261? if you had before, would you provide us the cause and effect?" patient status: no patient injury.Type of intervention no information.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with piece that had fragmented off of the event unit.Visual inspection confirmed the valve of the laparoscopic cap had broken off.The fragment completed the missing portion on the duckbill.Based on the condition of the returned unit, it is likely that the fragmentation was caused by non-axial insertion of the trocar through the laparoscopic cap.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Name of procedure being performed: unknown.Detailed description of event: hospital: [name] "the valve part broke down and dropped off from the center of the cap, when the surgeon inserted the 12 mm kii trocker into the cap during the treatment.As we checked the actual product, it was broken as see attached photos." [name] has two questions as below."1.Have you had the same product imperfection on the same lot#1361261? 2.If you had before, would you provide us the cause and effect?" additional information received via email on 30jan2020 from [name] from [name]: "yes, we retrieved all pieces.We used the product from our stock to complete the procedure, so probably it was the same product from lot#1361261.However, as soon as we finished the procedure, we scrapped everything we used for the procedure, sorry we have no proof." patient status: no patient injury.Type of intervention no information.

• Brand Name: C8501, S ALEXIS LAP SYS 6/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9673919
• Report Number: 2027111-2020-00344
• Device Sequence Number: 319427
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)220624(30)01(10)1361261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: C8501
• Device Catalogue Number: 101357001
• Device Lot Number: 1361261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM KII TROCAR